Qc Specialist Ii

1 week ago

Tuas, Singapore Novartis Full time

**Summary**:
This role will be responsible to establish and ensure testing of drug substance release and stability testing including testing of intermediates in process control samples and lab operations are accordance with written testing SOP’s and local/international regulations.

**About the Role**:
**QC Specialist II**

**About the Role**:
This role will be responsible to establish and ensure testing of drug substance release and stability testing including testing of intermediates in process control samples and lab operations are accordance with written testing SOP’s and local/international regulations.

**Key Responsibilities**:

- Ensure all activities in compliance with cGxP, incl. data integrity
- Review and approval of analytical data / tests (analytical release).
- Maintain and calibrate equipment incl. plan preparation
- Support in supplier qualification, trending and analysis of KPI/KQI.
- Support sample planning and sampling execution.
- Stability testing (projects) - protocol preparation, evaluation, report preparation
- Reporting (stability plan preparation, trend analysis, evaluation)
- Performance of stability studies, protocols and comparative reports for supplier qualification.

**Essential Requirements**:

- Professional experience (3-5 years) in the pharmaceutical sector or in the manufacture of active substances in analytical laboratories in a GMP environment or equivalent; Collaborating across boundaries; Functional Breadth; efficient inter and intra-departmental communications.
- Breakthrough Analysis; Being Resilient; Operational Excellence; Continuous Learning; Digital & Tech Savvy.
- Laboratory equipment; Quality Control (QC) Testing; Quality Control Sampling; Knowledge of TQM and related industry GxP standards and processes; Laboratory Excellence; Quality decision making

**Desirable Requirements**:

- University degree or equivalent experience in Pharmacy or Chemistry or equivalent + 0-4 years working experience

Division

Operations

Business Unit

Pharmaceuticals

Location

Singapore

Site

Tuas South Avenue

Company / Legal Entity

SG12 (FCRS = SG012) Novartis Singapore Pharmaceutical Manufacturing Pte Ltd

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

No

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